Capsule oxymatrine in the treatment of liver fibrosis in patients with chronic virus hepatitis: A randomized、double blind、placebo-controlled、multicenter clinical study(II)

Objective To evaluate the efficacy and safety of oxymatrine capsule in treatment of liver fibrosis in patients with chronic virus hepatitis. Methods It was a randomized、double blind、placebo controlled、multicenter clinical study.144 patients were divided into capsule oxymarine group(group A) and placebo group(group B).The course was 52 weeks. Patients visited once every 12 weeks and the last visit at 12 weeks after the cessation of treatment. All patients had liver biopsy before treatment, part of them had a second liver biopsy at the end of therapy. Clinical symptoms、liver function test、serum markers of liver fibrosis were tested, ultrasound evaluation was performed before, during the course and at the end of therapy.Results 144 patients enrolled in the study. 132 patients completed the study according to the protocol. 49 patients had liver biopsy twice, 25 patients in group A and 24 in group B. At the end of therapy, significant improvement of the degree of liver fibrosis and inflammatory of SSS were noted in group A. The total effective rate of liver fibrosis in histopathology is 48.00%,much higher than that of 4.17% in group B( P 0.05). Significant improvement of serum markers of liver fibrosis. such as HA and PⅢP in group A was seen( P 0.05).The total effective rate of serum markers of liver fibrosis at the end of therapy in group A was 68.19%, much higher than that of 34.85% in group B( P 0.05). The total effective rate of non invasion markers of liver fibrosis at the end of therapy in group A was 66.67%, much higher than that of 30.30% in group B( P 0.05).The rate of adverse event is similar in both groups. Conclusion Oxymatrine capsule is effective and safe in treatment of liver fibrosis with chronic virus hepatitis.